Source Documentation. Source Documentation. Objectives: At the conclusion of this discussion, participants will be able to: Define source document and source data Identify what data from nuclear medicine is considered to be source data
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Objectives: At the conclusion of this discussion, participants will be able to:
1.51 Source Data: All information in original records and certified copies of original records of clinical findings, observations, or other activities in a clinical trial necessary for the reconstruction and evaluation of the trial. Source data are contained in source documents (original records or certified copies).
1.52 Source Documents: Original documents, data, and records (e.g., hospital records, clinical and office charts, laboratory notes, memoranda, subjects' diaries or evaluation checklists, pharmacy dispensing records, recorded data from automated instruments, copies or transcriptions certified after verification as being accurate and complete, microfiches, photographic negatives, microfilm or magnetic media, x-rays, subject files, and records kept at the pharmacy, at the laboratories, and at medico-technical departments involved in the clinical trial).
Good source document “hygiene” prevents:
Sample provided by Cellectar, Inc.
Nuclear M. Technologist, 25 Jan 2010
“A printed, optical, or electronic document designed to record all of the protocol-required information to be reported to the sponsor for each trial subject”
“A record of clinical study observations and other information that a study protocol designates must be completed for each subject”
CDISC v. 8.0, 2009
a. Describe the investigator's source documents in terms of their organization, condition, completeness, and legibility.
b. Determine whether there is adequate documentation to ensure that all subjects were alive and available for the duration of their stated participation in the study.
c. Determine whether the records contain:
Case Report Forms (CRFs)
a. Describe the process for obtaining and recording information in CRFs.
b. Compare the source documents with the CRFs and any background information provided (e.g., data tabulations provided by the sponsor) per the assignment memorandum and sampling plan (if applicable).
Case histories. An investigator is required to prepare and maintain adequate and accurate case histories that record all observations and other data pertinent to the investigation on each individual administered the investigational drug or employed as a control in the investigation. Case histories include the case report forms and supporting data including, for example, signed and dated consent forms and medical records including, for example, progress notes of the physician, the individual's hospital chart(s), and the nurses' notes. The case history for each individual shall document that informed consent was obtained prior to participation in the study.
The case history for each individual shall document that informed consent was obtained prior to participation in the study.
“The informed consent for the XXXXXX study was presented to the subject. The subject was given the opportunity to ask and have all questions answered. The consent form was signed and a copy was given to the subject.” (Signature/Date)